Disorders of the Gastrointestinal Tract

One of the most common and dangerous intestinal infections in the hospital setting is Clostridium difficile infection (CDI). CDI accounts for over 300,000 cases per year in the United States, being responsible for more deaths than all other gastrointestinal infections combined. Most patients respond to antibiotic treatment for CDI, however relapse is common (15-30%). There is an unmet medical need for a novel adjunct treatment that helps prevent recurrence of CDI after infection and the restoration of normal microbiota.

Osel is developing a novel live biotherapeutic product (LBP) that contains the butyric acid-producing bacterium Clostridium butyricum CBM588. Safety has been demonstrated for CBM588, both in the United States and Japan. The product promotes the restoration of normal microbiota and colonic epithelium and antagonizes the growth of enteric pathogens. CBM588 also has anti-inflammatory and immunomodulatory properties and has been shown to inhibit colitis in several models of inflammatory bowel disease.